Reporting Forms and Templates
As part of the reporting requirements of Clinical Investigations of Medical Devices by the NREC-MD, please use the appropriate templates and forms below.
The Cover Form should be completed by the Sponsor and be submitted to the National Office with any safety reports such as annual safety reports and reports of serious adverse events or device deficiencies. It should be submitted to the National Office promptly following identification of the event/deficiency.
Annual Progress Report:
Annual Progress Reports must be submitted to the National Office on the anniversary date of final NREC approval and for every year thereafter for the duration of the study.
Declaration of End of the Clinical Investigation:
The Declaration of End of the Clinical Investigation should be completed by the Sponsor (or legal representative in the European Union if the Sponsor is not established in the European Union). It should be submitted to the National Office within 90-days of the conclusion (last person - last visit) of the investigation.
End of Study Report:
The End of Study Report must be submitted to the National Office within 12 months of the end of the clinical investigation.